Myocardial Infarction, Percutaneous Coronary Intervention
Conditions
Keywords
tPA
Brief summary
STRIVE will evaluate the use of adjunctive, low-dose intracoronary tissue plasminogen activator during primary percutaneous coronary intervention (PCI) for patients with ST elevation myocardial infarction (STEMI) in reducing the incidence of post-procedural myocardial blush (MBG) grade 0/1 or distal embolization.
Detailed description
STRIVE is a prospective, 3-arm, parallel group, blinded, randomized controlled trial evaluating the efficacy of a novel approach to prevent and treat microvascular obstruction thereby reducing major cardiovascular events using intracoronary administration of very low-dose fibrinolytic (tissue plasminogen activator, tPA) directly into the culprit coronary artery during primary PCI.
Interventions
Recombinant tPA is a fibrin-specific 2nd generation plasminogen activator and thrombolytic drug.
OTHERSaline
Placebo
Sponsors
Heart and Stroke Foundation of Canada
Population Health Research Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patients with STEMI undergoing primary PCI and, 2. ECG changes indicating large territory STEMI (defined as ≥2mm ST-segment elevation in 2 contiguous anterior precordial leads; or ≥2mm ST-segment elevation in 2 inferior leads coupled with ST-segment depression in 2 contiguous anterior leads for a total ST-segment deviation of ≥8mm) and, 3. Randomization within 6 to 12 hours of symptom onset and, 4. Large thrombus burden with angiographic TIMI Thrombus Grade ≥3 after guidewire crossing.
Exclusion criteria
1. Active internal bleeding or high risk of bleeding or any prior intracranial bleeding. 2. Any other absolute or relative contraindication to fibrinolytic therapy. 3. Administration of a fibrinolytic ≤24hrs prior to randomization. 4. Cardiogenic shock on presentation. 5. Left bundle branch block (excluded because the ECG cannot be evaluated for ST segment resolution, an outcome of the study). 6. Planned upfront use of a glycoprotein IIb/IIIa inhibitor. 7. Any medical, geographic, or social factor making study participation impractical or precluding 1 month follow-up.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| MACE OR Myocardial Blush Grade 0/1 OR Distal Embolization OR Failure to Achieve ≥50% ST-segment Resolution | 30 days post-randomization | The primary efficacy variable is the binary composite outcome with the following components: * The occurrence of any of the MACE outcomes (cardiovascular death, myocardial re-infarction, cardiogenic shock and new onset heart failure) at 30 days post-randomization. * Post-procedural Myocardial Blush Grade of either 0 (Failure of dye to enter the microvasculature or persistent staining, suggesting leakage of the contrast medium into the extravascular space) or 1 (Dye enters slowly but fails to exit the microvasculature. Dye is present in the next injection (30 seconds)). * Post-procedural Distal embolization, defined as distal filling defect with an abrupt 'cut-off' in one of the peripheral coronary branches of the infarct related artery, distal to the angioplasty site following PCI). * Failure to achieve ≥50% ST-segment resolution post-procedure. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Complete ST-segment Resolution. | 30 minutes | Complete (≥70%) ST-segment resolution (worst lead) at 30 minutes post-PCI |
| CV Death, MI, Cardiogenic Shock or New Onset HF | 30 Days | Composite of cardiovascular death, myocardial re-infarction, cardiogenic shock or new onset heart failure. |
Countries
Canada
Outcome results
None listed